Phase 2 Prospective, Randomized, Double-Blind Pilot Study on Cardiac Output Following Corrective Open Heart Surgery in Children Less Than One Year: Use of Levosimendan Versus Milrinone.
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Cardiac output measured by a transesophageal probe
研究概览
简要总结
Pediatric patients, especially infants undergoing open heart surgery have a predictable fall in cardiac index 6 to 18 hours after surgery, the so-called low cardiac output syndrome (LCOS). Patients, who have LCOS require more monitoring, more medication and a longer stay in intensive care unit. To prevent LCOS the phosphodiesterase inhibitor milrinone is routinely used during the first 24 hours after surgery. Levosimendan, a calcium- sensitizer improves cardiac muscle contractile force, vascular smooth muscle relaxation and coronary blood flow through calcium sensitization of the myocardial contractile filaments and opening of potassium channels without increasing oxygen consumption of the heart muscle cells. As the myocardium of infants is more calcium dependent than in later life, levosimendan should be of special benefit in this age group. The purpose of this study is to investigate whether levosimendan is superior to milrinone in preventing LCOS in infants after corrective open heart surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age younger than one year
- •corrective open heart surgery with biventricular repair, except tetralogy of fallot
排除标准
- •Missing written consent of parents
- •Weight less than 3 kg
- •preoperative LCOS
- •gestational age less than 36 weeks
- •preexisting renal failure
- •preexisting thrombopenia
- •preoperative cardiopulmonary resuscitation
- •preoperative use of milrinone or levosimendan
研究组 & 干预措施
1
干预措施: Levosimendan (Drug)
2
干预措施: Milrinone (Drug)
结局指标
主要结局
Cardiac output measured by a transesophageal probe
时间窗: 48 hours
次要结局
- Changes in mixed venous saturation(48 hours)
- Serum lactate levels(48 hours)
- Cardiac output and ventricular function assessed by echocardiography(48 hours)
- Mean arterial, left atrial and central venous pressure(48 hours)
- Need of catecholamines assessed with the inotropic score(48 hours)
- Urine output(48 hours)